Phase 4 Study of the Effects of Pravastatin on Cholesterol Levels, Inflammation and Cognition in Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12
研究概览
简要总结
This study involves people with schizophrenia or schizoaffective disorder, who are currently taking antipsychotic medications. Some antipsychotic medications may cause an increase in cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in developing heart disease, diabetes and problems with brain function. The purpose of this study is to see if pravastatin can:
- Lower cholesterol
- Decrease inflammation
- Improve cognition in patients with schizophrenia
详细描述
This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age 18-68 years
- •Diagnosis of schizophrenia, any subtype, schizoaffective disorder, any subtype or schizophreniform disorder
- •Well established compliance with outpatient medications including their antipsychotic medication
排除标准
- •Inability to provide informed consent
- •Current substance and alcohol abuse
- •Significant medical illness, including congestive heart failure, severe cardiovascular disease, renal disease (serum creatinine > 1.5), severe hepatic impairment or active liver disease, anemia (hemoglobin <11.0 gm/dL), history of severe head injury, and not treated muscle disease.
- •Psychiatrically unstable
- •Women of child bearing potential who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
- •Subjects treated with anti-inflammatory drugs (including daily aspirin and ibuprofen), thiazide diuretics; agents that induce weight loss, and St. John's Wort will be excluded from the study
- •Current history of untreated thyroid disease
- •Current treatment with insulin
- •Subjects being treated with drugs such as: colchicine, azole antifungals (fluconazole, ketoconazole, itraconazole); macrolide antibiotics (clarithromycin, erythromycin); HIV protease inhibitors (ritonavir, indinavir, saquinavir, nelfinavir) that inhibit the CYP 450 3A liver enzyme
- •Known hypersensitivity to pravastatin or any of its components
研究组 & 干预措施
pravastatin
pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks
干预措施: Pravastatin (Drug)
Placebo
placebo, once a day, shortly after baseline for 12 consecutive weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Positive and Negative Syndrome Scale (PANSS) General Score From Baseline to Week 12
时间窗: Baseline, week 12
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 15-105. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.
Change in LDL-cholesterol Between Baseline and Week 12
时间窗: Baseline, week 12
Change in C-Reactive Protein (CRP) From Baseline to Week 12
时间窗: Baseline, week 12
Change in MATRICS Neuropsychological Battery Composite Score From Baseline to Week 12
时间窗: Baseline, week 12
The Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery measures cognitive functioning within 7 domains: speed of processing, attention/vigilance, working memory (non verbal and verbal), verbal learning, visual learning, reasoning and problem solving and social cognition. The composite score is calculated by the MATRICS computer program, which equally weights each of the 7 domain scores. The range of composite scores is 20-80. Higher scores indicate higher levels or cognitive functioning, while lower scores indicate lower levels of cognitive functioning.
Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 12
时间窗: Baseline, week 12
The Positive and Negative Syndrome Scale (PANSS) is a scale used to rate severity of schizophrenia. All items are summed to calculate the total score. The scale range is 30-210. Better outcomes have lower numbers and worse outcomes have higher numbers.
Change in Positive and Negative Syndrome Scale (PANSS) Positive Score From Baseline to Week 12
时间窗: Baseline, week 12
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.
Change in Positive and Negative Syndrome Scale (PANSS) Negative Score From Baseline to Week 12
时间窗: Baseline, week 12
This is a subscale of the Positive and Negative Syndrome Scale (PANSS). The range for this subscale is 7-49. All items are summed to calculate the total score. Better outcomes have lower numbers and worse outcomes have higher numbers.
次要结局
未报告次要终点
研究者
David C. Henderson
Associate Professor of Psychiatry
Massachusetts General Hospital